Federal Register / Vol. 86, No. 136 / Tuesday, July 20, 2021 / Notices 38349 

Dated: July 15, 2021. 

David W. Freeman, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–15366 Filed 7–19–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

[FWS–HQ–FAC–2021–N167; 

FXFR13110900000 201 FF09F11000; OMB 

Control Number 1018–New] 

Agency Information Collection 

Activities; Administration of U.S. Fish 

and Wildlife Service Investigational 

New Animal Drug (INAD) Program 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Notice of information collection; 

request for comment. 

SUMMARY: In accordance with the 

Paperwork Reduction Act of 1995, we, 

the U.S. Fish and Wildlife Service 

(Service), are proposing a new 

information collection in use without 

Office of Management and Budget 

(OMB) approval. 

DATES: Interested persons are invited to 

submit comments on or before 

September 20, 2021. 

ADDRESSES: Send your comments on the 

information collection request (ICR) by 

mail to the Service Information 

Collection Clearance Officer, U.S. Fish 

and Wildlife Service, MS: PRB (JAO/ 

3W), 5275 Leesburg Pike, Falls Church, 

VA 22041–3803 (mail); or by email to 

Info_Coll@fws.gov. Please reference 

OMB Control Number ‘‘1018–INAD’’ in 

the subject line of your comments. 

FOR FURTHER INFORMATION CONTACT: To 

request additional information about 

this ICR, contact Madonna L. Baucum, 

Service Information Collection 

Clearance Officer, by email at Info_

Coll@fws.gov, or by telephone at (703) 

358–2503. Individuals who are hearing 

or speech impaired may call the Federal 

Relay Service at 1–800–877–8339 for 

TTY assistance. 

SUPPLEMENTARY INFORMATION: In 

accordance with the Paperwork 

Reduction Act of 1995 (PRA, 44 U.S.C. 

3501 et seq.) and 5 CFR 1320.8(d)(1), we 

provide the general public and other 

Federal agencies with an opportunity to 

comment on new, proposed, revised, 

and continuing collections of 

information. This helps us assess the 

impact of our information collection 

requirements and minimize the public’s 

reporting burden. It also helps the 

public understand our information 

collection requirements and provide the 

requested data in the desired format. 

As part of our continuing effort to 

reduce paperwork and respondent 

burdens, we invite the public and other 

Federal agencies to comment on new, 

proposed, revised, and continuing 

collections of information. This helps us 

assess the impact of our information 

collection requirements and minimize 

the public’s reporting burden. It also 

helps the public understand our 

information collection requirements and 

provide the requested data in the 

desired format. 

We are especially interested in public 

comment addressing the following: 

(1) Whether or not the collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether or not the 

information will have practical utility; 

(2) The accuracy of our estimate of the 

burden for this collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) Ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and 

(4) How might the agency minimize 

the burden of the collection of 

information on those who are to 

respond, including through the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology, e.g., permitting 

electronic submission of response. 

Comments that you submit in 

response to this notice are a matter of 

public record. We will include or 

summarize each comment in our request 

to OMB to approve this ICR. Before 

including your address, phone number, 

email address, or other personal 

identifying information in your 

comment, you should be aware that 

your entire comment—including your 

personal identifying information—may 

be made publicly available at any time. 

While you can ask us in your comment 

to withhold your personal identifying 

information from public review, we 

cannot guarantee that we will be able to 

do so. 

Abstract: The Aquatic Animal Drug 

Approval Partnership (AADAP) Program 

is part of the Fish and Aquatic 

Conservation fish health network. It is 

the only program in the United States 

singularly dedicated to obtaining U.S. 

Food and Drug Administration (FDA) 

approval of new medications needed for 

use in fish culture and fisheries 

management. Ultimately, the AADAP 

program allows fisheries professionals 

to more effectively and efficiently rear 

and manage a variety of fish species to 

meet production goals, stock healthy 

fish, and maintain a healthy 

environment. In order for participants 

(U.S. aquaculture facilities or 

researchers) to be able to use an 

unapproved drug under AADAP’s 

National Investigational New Animal 

Drug (INAD) Program, they need to 

follow the FDA-approved study 

protocol(s) and submit the required data 

forms, including the INAD treatment 

data, to AADAP’s INAD Program. 

There are 18 approved INADs 

approved for use within the Service’s 

INAD Program (see fws.gov/fisheries/ 

aadap/inads.html) described as follows: 

Medicated Feeds 

Florfenicol (Aquaflor®) INAD #10– 

697—Aquaflor® is an aquaculture 

premix containing florfenicol and is 

only available through Merck Animal 

Health. The primary goal of field studies 

conducted under INAD #10–697 is to 

evaluate the efficacy of florfenicolmedicated feed for controlling mortality 

in a variety of fish species diagnosed 

with a variety of diseases that are 

caused by pathogens susceptible to 

florfenicol. 

Slice® (Emamectin Benzoate) INAD 

#11–370—SLICE® is an aquaculture 

premix containing emamectin benzoate 

and is only available through Merck 

Animal Health. SLICE® premix can be 

purchased through Merck Animal 

Health and sent to an aquaculture feed 

mill for top coating. The primary goal of 

field studies conducted under INAD 

#11–370 is to evaluate the efficacy of 

SLICE®-medicated feed and safety of 

SLICE® to control mortality caused by 

external parasites in a variety of 

freshwater and marine fish species. 

Oxytetracylcine dihydrate 

(Terramycin® 200 for Fish) INAD 

#9332—Terramycin 200® for fish is an 

aquaculture premix containing 

oxytetracycline dehydrate (OTC) and is 

available through Syndel USA. Feed 

medicated with OTC can be purchased 

from aquaculture feed mills and used to 

treat bacterial diseases or to apply a 

skeletal mark on the fish. The primary 

goal of field studies conducted under 

INAD #9332 is to generate additional 

OTC-medicated feed efficacy data which 

can be used to expand the existing OTC 

label claims. Five treatment options are 

allowed, and disposition of 

investigational animals (including 

withdrawal times) vary with treatment 

regimen. 

17a-methyltestosterone INAD #11– 

236—17a-methyltestosterone (MET) is 

an aquaculture premix and is only 

available through Rangen Inc. The 

primary goal of studies conducted under 

INAD #11–236 is to generate data 

evaluating the efficacy of MET 


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38350 Federal Register / Vol. 86, No. 136 / Tuesday, July 20, 2021 / Notices 

administered in feed to larval tilapia to 

produce populations comprised of 

>90% male fish. 

17a-methyltestosterone INAD #8557— 

17a-methyltestosterone (MET) is an 

aquaculture premix and is only 

available through Rangen Inc. The 

primary goal of studies conducted under 

INAD #8557 is to generate data 

evaluating the efficacy of MET 

administered in feed to larval rainbow 

trout and Atlantic salmon to produce 

masculinized female fish that produce 

sperm. 

17b-Estradiol INAD #12–671—17bestradiol (E2) will be administered as a 

medicated feed and is only available to 

FDA-approved facilities. The primary 

goal of studies conducted under INAD 

#12–671 is to generate data evaluating 

the efficacy of E2 administered in feed 

to larval brook trout to produce 

feminized male fish that produce eggs. 

Immersion 

Chloramine-T INAD #9321— 

Chloramine-T (CLT) is a powder that is 

applied as an immersion bath treatment. 

CLT is only available for purchase 

through Syndel USA or B.L. Mitchell, 

Inc. The primary goal of field studies 

conducted under INAD #9321 is to 

evaluate the efficacy of CLT for 

controlling mortality in a variety of 

freshwater fish species for bacterial 

diseases not currently listed on the 

approved label. Approval of INAD 

#9321 is for non-labeled use only and its 

use must comply with the approved 

label directions. 

Hydrogen peroxide (35% Perox Aid®) 

INAD #11–669—35% Perox-Aid®

(H2O2) is a liquid solution containing 

hydrogen peroxide that is applied as an 

immersion bath treatment. H2O2 is only 

available for purchase through Syndel 

USA. The primary goal of field studies 

conducted under INAD #11–669 is to 

evaluate the efficacy of H2O2 for 

controlling mortality caused by specific 

ectoparasites in freshwater or marine 

finfish species. It is also expected that 

the additional data will be used to 

expand the current H2O2 label claim. 

Approval of INAD #11–669 is for nonlabeled use only and its use must 

comply with the approved label 

directions. 

Oxytetracycline hydrochloride INAD 

#9033—Oxytetracycline hydrochloride 

(OTIMM) is an aquaculture premix 

containing oxytetracycline 

hydrochloride and is available through 

Pharmgate. OTIMM is available for 

purchase through many local farm and 

ranch stores or veterinarian supply 

outlets. The primary goal of field studies 

conducted under INAD #9033 is to 

evaluate the efficacy of OTIMM for 

controlling mortality in a variety of 

freshwater and marine finfish species 

for bacterial diseases. Immersion 

therapy is often the only option when 

treating young fish not yet accustomed 

to feeding on man-made fish diets. 

Diquat® INAD #10–969—Reward®

(DQT) is a liquid concentrate containing 

diquat dibromide that is applied as an 

immersion bath treatment. DQT is 

available for purchase through many 

local farm and ranch stores or through 

Syngenta Crop Protection, LLC. The 

primary goal of field studies conducted 

under INAD #10–969 is to evaluate the 

efficacy of DQT for controlling mortality 

in all freshwater-reared finfish 

diagnosed with BGD or external 

flavobacteriosis. 

Sedatives 

AQUI–S®20E INAD #11–741—AquiS®20E is a liquid containing 10% 

eugenol that is applied as an immersion 

bath treatment. Aqui-S®20E is only 

available for purchase through 

AquaTactics Fish Health. The primary 

goal of field studies conducted under 

INAD #11–741 is to evaluate the efficacy 

of Aqui-S®20E for use as an anesthetic/ 

sedative in all freshwater-reared finfish, 

freshwater prawn, all saltwater-reared 

finfish, and sharks. 

Spawning Aids 

Lutenizing Hormone—Releasing 

Hormone (LHRHa) INAD #8061— 

Luteinizing Hormone—Releasing 

Hormone analogue (LHRHa) is a 

solution that is applied as either an 

intraperitoneal (IP) or intramuscular 

(IM) injection. LHRHa is only available 

for purchase through Syndel USA. The 

use of hormones to induce spawning in 

fish is critical to the success of many 

aquatic programs that need hormone 

treatment to complete final gamete 

maturation to ensure spawning. The 

primary goal of field studies conducted 

under INAD #8061 is to generate data to 

help determine appropriate LHRHa 

treatment regimens for inducing gamete 

maturation in a variety of cultured and 

wildstock finfish species. 

GnRH IIa Chicken Gonadotropin— 

Releasing Hormone II analog INAD #13– 

345—GnRH IIa is a synthetic peptide 

analogue of chicken gonadotropinreleasing hormone (cGnRH IIa). It is 

presented as a dry powder to be 

resuspended in saline solution for IP 

injection and is only available for 

purchase through AquaTactics Fish 

Health. The use of hormones to induce 

spawning in fish is critical to the 

success of many aquatic programs that 

need hormone treatment to complete 

final gamete maturation to ensure 

spawning. The primary goal of field 

studies conducted under INAD #13–345 

is to generate data to help determine 

appropriate GnRH IIa treatment 

regimens for use as a spawning aid for 

female ictalurids. 

Ovaplant® Salmon Gonadotropin— 

Releasing Hormone analoque (sGnRHa) 

INAD #11–375—Ovaplant® is a 

synthetic peptide analogue of salmon 

gonadotropin-releasing hormone 

(sGnRHa). It is presented in a 

biodegradable cholesterol-based matrix 

as an IM pellet implant and is only 

available for purchase through Syndel 

USA. The use of hormones to induce 

spawning in fish is critical to the 

success of many aquatic programs that 

need hormone treatment to complete 

final gamete maturation to ensure 

spawning. The primary goal of field 

studies conducted under INAD #11–375 

is to generate data to help determine 

appropriate Ovaplant® treatment 

regimens. 

Ovaplant®–L Salmon Gonadotropin— 

Releasing Hormone analoque (sGnRHa) 

INAD #13–298—Ovaplant®-L is a 

synthetic peptide analogue of salmon 

gonadotropin-releasing hormone 

(sGnRHa). It is presented in a sustained 

release gel for injection and is only 

available for purchase through Syndel 

USA. The use of hormones to induce 

spawning in fish is critical to the 

success of many aquatic programs that 

need hormone treatment to complete 

final gamete maturation to ensure 

spawning. The primary goal of field 

studies conducted under INAD #13–298 

is to generate data to help determine 

appropriate Ovaplant-L treatment 

regimens for inducing gamete 

maturation in a variety of cultured 

finfish species. 

Common Carp Pituitary (CCP) INAD 

#8391—Common carp pituitary (CCP) is 

a powder (for suspension) that is 

applied as either an IP or IM injection. 

CCP is only available for purchase 

through Argent Aquaculture. The use of 

hormones to induce spawning in fish is 

critical to the success of many aquatic 

programs that need hormone treatment 

to complete final gamete maturation to 

ensure spawning. The primary goal of 

field studies conducted under INAD 

#8391 is to generate data to help 

determine appropriate CCP treatment 

regimens for inducing gamete 

maturation in a variety of cultured and 

wildstock finfish species. 

Marking 

Calcein (Se-Mark®) INAD #10–987— 

Calcein (Se-Mark®) is a liquid that 

contains 1% calcein for bath marking 

treatments on finfish and select 

freshwater mussels. Calcein is only 

available for purchase through Syndel 


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Federal Register / Vol. 86, No. 136 / Tuesday, July 20, 2021 / Notices 38351 

USA. Calcein is a fluorochrome 

compound that chemically binds with 

alkaline earth metals such as calcium, 

and upon binding, shows a marked 

increase in fluorescence when excited 

with blue light of about 500 nm 

wavelength. The primary goal of field 

studies conducted under INAD #10–987 

is to establish the effectiveness of 

calcein to mark fin rays, scales, otoliths, 

and other calcified fish, oysters, or 

selected mussel tissues via immersion 

baths. This is a non-lethal marking 

evaluation method. 

Injectable 

Erythromycin 200 Injectable INAD 

#12–781—Erymicin 200 Injection 

(Erymicin 200) is a solution that 

contains erythromycin for injection on 

juvenile and adult Salmonids. Erymicin 

200 is only available for purchase 

through Syndel USA. The primary goal 

of field studies conducted under INAD 

#12–781 is to evaluate the efficacy of 

erythromycin for (1) controlling 

mortality caused by BKD (causative 

agent: Renibacterium salmoninarum) in 

salmonid species; and (2) control the 

vertical transmission of R. 

salmoninarum from BKD positive 

female broodstock to eggs/progeny. 

Approved INAD study protocols 

require submission of the following 

forms associated with the data 

collection: 

• Form–W: Worksheet (all INADs); 

• Form–1: Report on Receipt of Drug 

(all INADs); 

• Form–2A or 2B: Chemical Use Log 

(all INADs); 

• Form–3: Diagnosis, Treatment, and 

Mortality/Spawning/Anesthetic Record 

(all INADs); 

• Form–4: Necropsy Report Form 

(specific INADs); 

• Form–4a: Report on Efficacy 

Determination Sample (specific INADs); 

and, 

• Form–5: Transfer of Treated 

Fingerling (specific INADs). 

The INAD forms listed above collect 

the following information from program 

participants (specific information may 

vary depending on INAD protocol used): 

• Study identification number and 

title; 

• Sponsor name and contact 

information; 

• Facility name; 

• Study director and contact 

information; 

• Principal clinical field trial 

coordinator name; 

• Study monitor’s name and 

addresses; 

• Investigator’s name and addresses; 

• Proposed study starting and 

completion dates; 

• Background, purpose, and 

objectives of study; 

• Study materials; 

• Experimental units; 

• Entrance criteria; 

• Identification of treatment groups; 

• Treatment schedules; 

• Treatment response parameters; 

• Recordkeeping procedures; 

• Disposition of investigational 

animals; 

• Disposition of investigational drug; 

• Data handling, quality control, 

monitoring, and administrative 

responsibilities; 

• Plans for data analysis; 

• Protocol and protocol amendments; 

and, 

• Protocol deviations. 

The Service’s AADAP Program will 

use the information that is collected on 

the study forms to ensure the studies are 

following the guidelines set by the FDA. 

The study data will be downloaded to 

a spreadsheet where it will be analyzed 

for compliance. Summary reports will 

be created from the data collected from 

the forms and will be submitted to the 

FDA, as required. Submission of the 

data forms is required by the FDA for 

the facility to participate in the INAD 

Program. 

A cooperative agreement is also 

needed between the participating 

companies/agencies and the Service’s 

AADAP Program. This agreement 

establishes obligations to be met and 

procedures to be followed by the 

Service and participant to establish and 

maintain cooperative INADs to enable 

the use of certain drugs and chemicals 

under the INAD process as set forth by 

the FDA. The goal of this agreement is 

to consolidate the INAD process; 

eliminate duplication of effort; reduce 

workloads and costs; and ensure needed 

drugs are made available to aquaculture 

and fisheries management facilities in 

the U.S. in compliance with FDA 

regulations. 

Additional information for the INAD 

Program and how to participate can be 

found at the following link: https://

www.fws.gov/fisheries/aadap/inaduniversity.html. This web page 

describes frequently asked questions 

regarding how to participate in the 

INAD Program and what is expected of 

the participants. The site also includes 

the investigator and monitor guides 

created to explain the INAD Program 

process to study participants. We are 

currently developing additional study 

templates for the INADs for use as a 

guide for filling out the forms. These 

templates will provide study 

participants with helpful information to 

correctly complete each form. We also 

created a user manual for the online 

INAD database used to enter the data 

that also describes each step of the 

database for the INAD participants. 

Title of Collection: Administration of 

U.S. Fish and Wildlife Service 

Investigational New Animal Drug 

(INAD) Program. 

OMB Control Number: 1018–New. 

Form Number(s): Form–W, Form–1, 

Form–2A or 2B, Form–3, Form–4, 

Form–4a, and Form–5. 

Type of Review: Existing collection in 

use without an OMB control number. 

Respondents/Affected Public: 

Respondents will be the private 

aquaculture facilities; universities; and 

State, local, and Tribal governments that 

have a need to use INADs. 

Respondent’s Obligation: Required to 

obtain or retain a benefit. 

Frequency of Collection: One time for 

the initial registration and submission of 

cooperative agreement, and on occasion 

for submission of study data. 

Total Estimated Annual Nonhour 

Burden Cost: There is an enrollment fee 

that is currently $700 per INAD per 

facility each year as of 2021. The facility 

is also responsible for purchasing the 

INAD from the appropriate drug 

supplier. All equipment that would be 

used for the INAD studies is typically 

standard equipment already used by the 

facilities. 

Requirement 

Average 

number of 

annual 

respondents 

Average 

number of 

responses 

each 

Average 

number of 

annual 

responses * 

Average 

completion 

time per 

response 

(hours) 

Estimated 

annual burden 

hours * 

Cooperative Agreement 

Private Sector ...................................................................... 15 1 15 2 30 

Government ......................................................................... 5 1 5 2 10 


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38352 Federal Register / Vol. 86, No. 136 / Tuesday, July 20, 2021 / Notices 

Requirement 

Average 

number of 

annual 

respondents 

Average 

number of 

responses 

each 

Average 

number of 

annual 

responses * 

Average 

completion 

time per 

response 

(hours) 

Estimated 

annual burden 

hours * 

Medicated Feed—Florfenicol (Aquaflor®) INAD #10–697 

Private Sector ...................................................................... 4 1 4 0.25 1 

Government ......................................................................... 4 1 4 0.25 1 

Medicated Feed—Slice® (Emamectin Benzoate) INAD #11–370 

Private Sector ...................................................................... 5 1 5 0.25 1 

Government ......................................................................... 4 1 4 0.25 1 

Medicated Feed—Oxytetracylcine dihydrate (Terramycin® 200 for Fish) INAD #9332 

Private Sector ...................................................................... 5 1 5 0.25 1 

Government ......................................................................... 16 1 16 0.25 4 

Medicated Feed—17α-methyltestosterone INAD #11–236 

Private Sector ...................................................................... 4 1 4 0.25 1 

Government ......................................................................... 5 1 5 0.25 1 

Medicated Feed—17α-methyltestosterone INAD #8557 

Private Sector ...................................................................... 5 1 5 0.25 1 

Government ......................................................................... 1 1 1 0.25 0 

Medicated Feed—17β-Estradiol INAD #12–671 

Private Sector ...................................................................... 1 1 1 0.25 0 

Government ......................................................................... 1 1 1 0.25 0 

Immersion—Chloramine-T INAD #9321 

Private Sector ...................................................................... 1 1 1 0.25 0 

Government ......................................................................... 8 1 8 0.25 2 

Immersion—Hydrogen peroxide (35% Perox Aid®) INAD #11–669 

Private Sector ...................................................................... 1 5 5 0.25 1 

Government ......................................................................... 2 2 4 0.25 1 

Immersion—Oxytetracycline hydrochloride INAD #9033 

Private Sector ...................................................................... 1 1 1 0.25 0 

Government ......................................................................... 2 2 4 0.25 1 

Immersion—Diquat® INAD #10–969 

Private Sector ...................................................................... 1 1 1 0.25 0 

Government ......................................................................... 7 2 14 0.25 4 

Sedative—AQUI-S®20E INAD #11–741 

Private Sector ...................................................................... 11 1 11 0.25 3 

Government ......................................................................... 73 1 73 0.25 18 

Spawning Aid—Lutenizing Hormone—Releasing Hormone (LHRHa) INAD #8061 

Private Sector ...................................................................... 19 1 19 0.25 5 

Government ......................................................................... 7 2 14 0.25 4 

Spawning Aid—GnRH IIa Chicken Gonadotropin—Releasing Hormone II analog INAD #13–345 

Private Sector ...................................................................... 9 1 9 0.25 2 

Government ......................................................................... 1 1 1 0.25 0 

Spawning Aid—Ovaplant® Salmon Gonadotropin—Releasing Hormone analoque (sGnRHa) INAD #11–375 

Private Sector ...................................................................... 5 1 5 0.25 1 

Government ......................................................................... 12 1 12 0.25 3 


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Requirement 

Average 

number of 

annual 

respondents 

Average 

number of 

responses 

each 

Average 

number of 

annual 

responses * 

Average 

completion 

time per 

response 

(hours) 

Estimated 

annual burden 

hours * 

Spawning Aid—Ovaplant®-L Salmon Gonadotropin—Releasing Hormone analoque (sGnRHa) INAD #13–298 

Private Sector ...................................................................... 1 1 1 0.25 0 

Government ......................................................................... 4 1 4 0.25 1 

Spawning Aid—Common Carp Pituitary (CCP) INAD #8391 

Private Sector ...................................................................... 5 1 5 0.25 1 

Government ......................................................................... 7 2 14 0.25 4 

Marking—Calcein (Se-Mark®) INAD #10–987 

Private Sector ...................................................................... 1 1 1 0.25 0 

Government ......................................................................... 2 1 2 0.25 1 

Injectable—Erythromycin 200 Injectable INAD #12–781 

Private Sector ...................................................................... 2 1 2 0.25 1 

≤Government ....................................................................... 14 1 14 0.25 4 

Form-W: ‘‘Worksheet for Designing Individual Field Trials’’ 

Private Sector ...................................................................... 63 3 189 1 189 

Government ......................................................................... 148 3 444 1 444 

Form-1: Report on Receipt of Drug 

Private Sector ...................................................................... 45 2 90 0.5 45 

Government ......................................................................... 88 2 176 0.5 88 

Form FFC–2A or 2B: Chemical Use Log 

Private Sector ...................................................................... 63 3 189 0.25 47 

Government ......................................................................... 148 3 444 0.25 111 

Form-3: Diagnosis, Treatment, and Mortality Record 

Private Sector ...................................................................... 63 3 189 1.5 284 

Government ......................................................................... 148 3 444 1.5 666 

Form-4: Necropsy Report Form 

Private Sector ...................................................................... 27 1 27 0.5 14 

Government ......................................................................... 24 1 24 0.5 12 

Form-4a: Report on Efficacy Determination Sample 

Private Sector ...................................................................... 3 2 6 0.75 5 

Government ......................................................................... 3 2 6 0.75 5 

Form-5: Transfer of Treated Fingerling 

Private Sector ...................................................................... 2 8 16 0.5 8 

Government ......................................................................... 1 1 1 0.5 1 

Totals ............................................................................ 1,097 ........................ 2,545 ........................ 2,027 

* Rounded. 


khammond on DSKJM1Z7X2PROD with NOTICES
38354 Federal Register / Vol. 86, No. 136 / Tuesday, July 20, 2021 / Notices 

An agency may not conduct or 

sponsor and a person is not required to 

respond to a collection of information 

unless it displays a currently valid OMB 

control number. 

The authority for this action is the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

Madonna Baucum, 

Information Collection Clearance Officer, U.S. 

Fish and Wildlife Service. 

[FR Doc. 2021–15418 Filed 7–19–21; 8:45 am] 

BILLING CODE 4333–15–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

[Docket No. FWS–HQ–MB–2018–0090; 

FF09M22000–212–FXMB1231099BPP0] 

RIN 1018–BD76 

Economic Analysis for Proposed 

Regulations Governing the Take of 

Migratory Birds 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Proposed rule; document 

availability. 

SUMMARY: We announce the opportunity 

to review and comment on two 

economic analysis documents prepared 

during development of the proposed 

rule to revoke the January 7, 2021, rule 

governing the prohibitions on incidental 

take under the Migratory Bird Treaty 

Act. This document announces the 

availability of an initial regulatory 

flexibility analysis and a regulatory 

impact analysis for public review. 

DATES: Submit comments by August 19, 

2021. 

ADDRESSES: You may submit comments 

by one of the following methods: 

(1) Electronically: Go to the Federal 

eRulemaking Portal: https://

www.regulations.gov/docket/FWS-HQMB-2018-0090/document. You may 

submit a comment by clicking on 

‘‘Comment.’’ Please ensure you have 

located the correct document before 

submitting your comments. 

(2) By hard copy: Submit by U.S. mail 

to: Public Comments Processing, Attn: 

FWS–HQ–MB–2018–0090, U.S. Fish 

and Wildlife Service, MS: JAO/3W, 

5275 Leesburg Pike, Falls Church, VA 

22041–3803. 

We request that you send comments 

only by the methods described above. 

We will post all comments on https:// 

www.regulations.gov. This generally 

means that we will post any personal 

information you provide us (see Public 

Comments, below, for more 

information). 

FOR FURTHER INFORMATION CONTACT: 

Jerome Ford, Assistant Director, 

Migratory Birds, at 202–208–1050. 

SUPPLEMENTARY INFORMATION: 

Background 

On January 7, 2021, the Service 

published a final rule defining the scope 

of the Migratory Bird Treaty Act 

(MBTA; 16 U.S.C. 703 et seq.) as it 

applies to conduct resulting in the 

injury or death of migratory birds 

protected by the MBTA (86 FR 1134) 

(hereafter referred to as the ‘‘January 7 

rule’’). The January 7 rule codified an 

interpretation of the MBTA set forth in 

a 2017 legal opinion of the Solicitor of 

the Department of the Interior, 

Solicitor’s Opinion M–37050, which 

concluded that the MBTA does not 

prohibit incidental take. 

Following Council on Environmental 

Quality regulations that implement the 

National Environmental Policy Act (42 

U.S.C. 4321 et seq.), the Service 

prepared a final environmental impact 

statement (EIS) for the January 7 rule: 

‘‘Final Environmental Impact Statement; 

Regulations Governing Take of 

Migratory Birds,’’ available on http://

www.regulations.gov in Docket No. 

FWS–HQ–MB–2018–0090 (https://

www.regulations.gov/document/FWSHQ-MB-2018-0090-14242). The 

alternatives analyzed in that EIS cover 

the effects of interpreting the MBTA 

both to include and exclude incidental 

take. We issued a record of decision 

based on the final EIS. The Service also 

prepared a regulatory impact analysis 

(RIA) to support the January 7 rule, 

available on http://www.regulations.gov 

in Docket No. FWS–HQ–MB–2018–0090 

(https://www.regulations.gov/document/ 

FWS-HQ-MB-2018-0090-14241). That 

RIA analyzed the economic impacts of 

three alternatives: A No Action 

Alternative—Retain the existing legal 

interpretation under M–37050 that the 

MBTA excludes incidental take; 

Alternative A—Promulgate regulations 

that define the scope of the MBTA to 

exclude incidental take; and Alternative 

B—Promulgate regulations that define 

the scope of the MBTA to include 

incidental take. 

On May 7, 2021, the Service 

published in the Federal Register (86 

FR 24573) a proposed rule seeking 

public comment on whether the Service 

should revoke the January 7 rule, which 

defined the scope of the MBTA as it 

applies to conduct resulting in the 

injury or death of migratory birds 

protected by the MBTA. This proposed 

rule is available on http://

www.regulations.gov in Docket No. 

FWS–HQ–MB–2018–0090 (https://

www.regulations.gov/document/FWSHQ-MB-2018-0090-18943). For the May 

7, 2021, proposed rule, we modified the 

analysis in the RIA for the January 7 

rule, given that the January 7 rule went 

into effect on March 8, 2021. The 

regulatory impact analysis presented for 

the proposed rule revises the 

alternatives to reflect the current 

baseline with the January 7 rule in 

effect. While the proposed rule does not 

itself propose codification of a new 

regulation that interprets the MBTA to 

prohibit incidental take, the effects of 

the removal of the January 7 rule are 

substantially similar to those described 

in Alternative B of the RIA for the 

January 7 rule. Revoking the January 7 

rule would have the effect of reverting 

the government’s interpretation of the 

MBTA to prohibit incidental take 

consistent with longstanding agency 

practice prior to publication of M– 

37050, subject to the exercise of 

enforcement discretion and the 

applicable judicial precedent in a given 

jurisdiction. Consistent with Alternative 

B, the Service will consider further 

steps to implement the MBTA 

consistent with an interpretation that it 

prohibits incidental take if it finalizes 

the proposed revocation rule. 

The Regulatory Flexibility Act of 1980 

(RFA; 5 U.S.C. 601 et seq.) requires 

agencies to evaluate the potential effects 

of their proposed and final rules on 

small businesses, small organizations, 

and small governmental jurisdictions. 

Section 603 of the RFA requires 

agencies to prepare and make available 

for public comment an initial regulatory 

flexibility analysis (IRFA) describing the 

impact of proposed rules on small 

entities unless the agency can certify 

under section 605(b) that the proposed 

rule, if promulgated, will not have a 

significant economic impact on a 

substantial number of small entities. 

Section 603(b) of the Act specifies that 

each IRFA must contain: 

D A description of the reasons why 

action by the agency is being 

considered; 

D A succinct statement of the 

objectives of, and legal basis for, the 

proposed rule; 

D A description—and, where feasible, 

an estimate of the number—of small 

entities to which the proposed rule will 

apply; 

D A description of the projected 

reporting, recordkeeping, and other 

compliance requirements of the 

proposed rule including an estimate of 

the classes of small entities that will be 

subject to the requirement and the type 

of professional skills necessary for 

preparation of the report or record; and 

D An identification, to the extent 

practicable, of all relevant Federal rules 


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